Adverse Effects - Medtronic Intersept 1351 Gebrauchsanweisung

• Only persons thoroughly trained in cardiopulmonary bypass procedures should use this device. Perfusion must be carefully and constantly
monitored.
• Each device is intended for single use only. Do not reuse or resterilize. Sterilized using ethylene oxide.
• To vent the reservoir, remove the yellow vented cap on the 0.6 cm (1/4 in) access port labeled VENT/VACUUM prior to use.
• The fluid pathway is sterile and nonpyrogenic. Inspect each package and device prior to use. Do not use if the package is opened or damaged or if
the device is damaged or the protective caps are not in place.
• Use aseptic technique in all procedures.
• Attach the tubing in such a manner as to prevent kinks or restrictions that may alter blood flow.
• Do not allow alcohol, alcohol-based fluids, anesthetic liquids (such as isoflurane), or corrosive solvents (such as acetone) to come in contact with
the product because they may jeopardize the structural integrity.
• If air bubbles and/or leaks are observed during priming and/or operation, these conditions may result in air embolism to the patient and/or fluid loss.
Continually monitor the extracorporeal circuit. Do not use the product if these conditions are observed.
• Clear all gas emboli from the extracorporeal circuit before initiating bypass. Gas emboli are hazardous to the patient.
• A standby reservoir should always be available during perfusion.
• Pressurizing the cardiotomy reservoir could result in leakage or damage. The reservoir must be vented at all times when using a roller pump in the
suction lines.
• If a vacuum source is being used, negative pressure should not exceed −200 mmHg.
• Blood that has been in the cardiotomy reservoir for 4 hours or more must not be reinfused.
4.1 Model 1351 Only
• The safe reinfusion of collected fluids and the assurance that fluids collected are safe for reinfusion is the responsibility of the attending physician.
• Chest drainage should be autotransfused on an hourly basis unless fewer than 50 mL of blood/fluid are collected hourly.
• If the filter occludes, nonfiltered blood may pass through the external shunt and enter the reservoir on the filtered side (Figure 3, number 1). If chest
drainage volume is excessive, nonfiltered blood may pass through the external shunt to the vent connector and back into the reservoir on the filtered
side of the reservoir (Figure 3, number 2). Any drainage that has passed to the filtered side of the cardiotomy reservoir through the external shunt
must be filtered prior to autotransfusion.
• A minimum reservoir level of 25 mL of blood should always be maintained to prevent passing an air embolus during reinfusion.
• It is not recommended that autotransfusion continue for more than 18 hours following surgery.
• Follow all accepted medical and nursing care routines for patients undergoing chest drainage.
5 Precautions
• Refer to the package labeling for storage temperature requirements.
• The maximum recommended flow rate is 2 L/min.
• Band all tubing connections.
• Follow a strict anticoagulation protocol and routinely monitor anticoagulation during all procedures.
• This device was designed for single patient use only. Do not reuse, reprocess, or resterilize this product. Reuse, reprocessing, or resterilization may
compromise the structural integrity of the device and create a risk of contamination of the device, which could result in patient injury, illness, or death.
• Dispose of the devices in accordance with local hospital, administrative, and other government policies.
• Additional warnings and precautions applicable to specific procedures can be found at appropriate places in the Instructions for Use.

6 Adverse effects

The following adverse effects are associated with the use of the product: allergic reaction, sensitization; blood loss, exsanguination, hypovolemia;
capillary leak syndrome; carcinogenicity; circulatory compromise; cytotoxicity; death; fever; hemolysis; hypercarbia/acidosis; hypotension; hypoxia;
impaired patient temperature management; infection; mutagenicity; neurological dysfunction/stroke, such as air embolism and post perfusion syndrome
(pump head); organ dysfunction; platelet dysfunction, thrombocytopenia; renal failure; reproductive harm in male neonatal/pediatric patients;
respiratory/pulmonary issues; sepsis, toxemia, blood toxicity; thrombotic and inflammatory responses, including excessive blood component activation;
thrombus dislodgement; and vasculature damage.
7 Information for products with Cortiva bioactive surface
The primary blood-contacting surfaces of the product are coated with Cortiva bioactive surface. This coated surface enhances blood compatibility and
provides a blood-contacting surface that is thromboresistant. Cortiva bioactive surface contains nonleaching heparin derived from porcine intestinal
mucosa 1 .
Caution: Product coated with Cortiva bioactive surface is intended for single use only. Resterilization may adversely affect the Cortiva bioactive surface.
Caution: Follow a strict anticoagulation protocol and routinely monitor anticoagulation during all procedures.
Warning: Do not store product coated with Cortiva bioactive surface above 40°C (104°F).
8 Instructions for use
8.1 Operating room - cardiopulmonary bypass
When using Model 1351/CB1351 for cardiopulmonary bypass in the operating room, follow this procedure:
1. Remove the device from the packaging carefully to ensure a sterile fluid pathway.
1 Nonleaching is defined as heparin at a level ≤0.1 IU/mL, as measured through clinically relevant extraction conditions.
11 English